FDA refuses to review Moderna's mRNA flu vaccine
摘要
美国食品药品监督管理局（FDA）拒绝受理莫德纳公司针对其mRNA流感疫苗的上市申请。莫德纳表示对此决定感到意外。FDA的拒绝理由涉及该公司名为mRNA-1010的疫苗三期临床试验设计，特别是其使用的对照疫苗。此举发生在由公开反对疫苗的罗伯特·F·肯尼迪领导的FDA首个任期内，该机构此前已大幅削减儿童疫苗建议并取消了针对潜在流行病威胁的mRNA疫苗研究资金。
The Food and Drug Administration has refused to review Moderna's application for an mRNA flu vaccine, the company revealed Tuesday.
While the move came as a surprise to the high-profile vaccine maker, it is just the latest hostility toward vaccines—and mRNA vaccines in particular—from an agency overseen by the fervent anti-vaccine activist Robert F. Kennedy Jr. In his first year in office, Kennedy has already dramatically slashed childhood vaccine recommendations and canceled $500 million in research funding for mRNA vaccines against potential pandemic threats.
In a news release late Tuesday, Moderna said it was blindsided by the FDA's refusal, which the FDA cited as being due to the design of the company's Phase 3 trial for its mRNA flu vaccine, dubbed mRNA-1010. Specifically, the FDA's rejection was over the comparator vaccine Moderna used.
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